Vitamin D Supplementation and Muscle Power, Strength and Physical Performance in Older Adults: A Randomized Controlled Trial.

BACKGROUND: Low 25-hydroxyvitamin D (25[OH]D) concentrations (<30 ng/mL [<50 nmol/L]) have been associated with muscle weakness and impaired physical performance in observational studies. However, the effect of vitamin D supplementation on changes in muscle strength and physical performance in randomized controlled trials has been mixed. OBJECTIVES: To determine the effect of daily vitamin D supplementation on leg power, strength, and physical performance in low-functioning older adults with 25(OH)D concentrations of 18 to <30 ng/mL. METHODS: In this double-blind, randomized controlled trial, 136 low-functioning [Short Physical Performance Battery (SPPB) scores ≤10] adults aged 65-89 y with 25(OH)D concentrations of 18 to <30 ng/mL were randomly assigned to 2000 IU/d vitamin D3 or placebo for 12 mo. Lower-extremity leg power (primary outcome), leg and grip strength, SPPB, timed up and go (TUG), postural sway, and gait velocity and spatiotemporal parameters (secondary outcomes) were assessed at baseline, 4 and 12 mo. A subset (n = 37) also underwent a muscle biopsy at baseline and 4 mo and muscle fiber composition and contractile properties were assessed. RESULTS: Participants' mean ± SD age and SPPB scores at baseline were 73.4 ± 6.3 y and 7.8 ± 1.8, respectively. Mean ± SD 25(OH)D concentrations at baseline and 12 mo were 19.4 ± 4.2 ng/mL and 28.6 ± 6.7 ng/mL in the vitamin D group and 19.9 ± 4.9 ng/mL and 20.2 ± 5.0 ng/mL in the placebo group for a mean ± SE difference of 9.1 ± 1.1 ng/mL (P < 0.0001). However, there were no differences in change in leg power, leg or grip strength, SPPB score, TUG, postural sway, or gait velocity and spatiotemporal parameters by intervention group over 12 mo or muscle fiber composition and contractile properties over 4 mo. CONCLUSIONS: In low-functioning older adults with 25(OH)D concentrations of 18 to <30 ng/mL, randomization to 2000 IU/d vitamin D3 did not result in improvements in leg power, strength, or physical performance or muscle fiber composition and contractile properties. This trial was registered at clinicaltrials.gov as NCT02015611.

The Association of Total Knee Arthroplasty With Weight Loss in the Look AHEAD (Action for Health in Diabetes) Clinical Trial.

BACKGROUND: Patients who have obesity seldom lose weight after total knee arthroplasty (TKA). The Look AHEAD (Action for Health in Diabetes) trial randomized patients with type 2 diabetes who were overweight or had obesity to a 10-year intensive lifestyle intervention (ILI) or diabetes support and education (DSE). METHODS: Of the total 5,145 participants enrolled who had a median 14-year follow-up, a subset of 4,624 met inclusion criteria. The ILI aimed at achieving and maintaining a 7% weight loss and included weekly counseling the first 6 months, with decreasing frequency thereafter. This secondary analysis was undertaken to determine what effects a TKA had on patients participating in a known successful weight loss program and specifically if there was a negative impact on weight loss or their Physical Component Score. RESULTS: The analysis suggests that the ILI remained effective for maintaining or losing weight after TKA. Participants in ILI had significantly greater percent weight loss than those in DSE both before and after TKA (ILI-DSE before TKA: -3.6% (-5.0, -2.3); after TKA: -3.7% (-4.1, -3.3); both P < .0001). When comparing percent weight loss before to after TKA, there was no significant difference within either the DSE or ILI group (least square means ± standard error ILI: -0.36% ± 0.3, P = .21; DSE: -0.41% ± 0.29, P = .16). Physical Component Scores improved after TKA (P < .001), but no difference was found between TKA ILI and DSE groups before or after surgery. CONCLUSION: Participants who had a TKA did not have an altered ability to adhere to intervention goals to maintain weight loss or obtain further weight loss. The data suggest patients who have obesity can lose weight after TKA on a weight loss program.

Association of cognition with leptin and vascular endothelial growth factor in individuals with type 2 diabetes mellitus.

OBJECTIVE: The 10-year intensive lifestyle intervention (ILI) of the Look AHEAD study left a legacy of relative deficits in cognitive function among participants who entered the clinical trial with obesity or a history of cardiovascular disease. We hypothesized that altered levels of two weight-sensitive proangiogenic cytokines, leptin and vascular endothelial growth factor (VEGF), accounted for this concerning finding. METHODS: Serum leptin and VEGF concentrations were determined in 1,279 Look AHEAD participants at baseline, proximal to cessation of the interventions (Epoch 1), and an average of 4 years later (Epoch 2). Up to four standardized assessments of attention, executive function, and memory were collected during follow-up. Mixed effects models were used to assess relative differences in leptin and VEGF concentrations between intervention groups and whether these accounted for changes in cognitive composite scores. RESULTS: ILI and diabetes support and education differences in VEGF, but not leptin, concentrations varied depending on baseline history of cardiovascular disease and obesity, but neither leptin nor VEGF concentrations accounted for the relative decrements in cognitive function in participants assigned to ILI. CONCLUSIONS: Alterations in two weight-sensitive proangiogenic cytokines did not account for the long-term adverse effects of ILI on cognitive function among adults with diabetes and either obesity or cardiovascular disease.

Estimating heterogeneity of physical function treatment response to caloric restriction among older adults with obesity.

Clinical trials conventionally test aggregate mean differences and assume homogeneous variances across treatment groups. However, significant response heterogeneity may exist. The purpose of this study was to model treatment response variability using gait speed change among older adults participating in caloric restriction (CR) trials. Eight randomized controlled trials (RCTs) with five- or six-month assessments were pooled, including 749 participants randomized to CR and 594 participants randomized to non-CR (NoCR). Statistical models compared means and variances by CR assignment and exercise assignment or select subgroups, testing for treatment differences and interactions for mean changes and standard deviations. Continuous equivalents of dichotomized variables were also fit. Models used a Bayesian framework, and posterior estimates were presented as means and 95% Bayesian credible intervals (BCI). At baseline, participants were 67.7 (SD = 5.4) years, 69.8% female, and 79.2% white, with a BMI of 33.9 (4.4) kg/m2. CR participants reduced body mass [CR: -7.7 (5.8) kg vs. NoCR: -0.9 (3.5) kg] and increased gait speed [CR: +0.10 (0.16) m/s vs. NoCR: +0.07 (0.15) m/s] more than NoCR participants. There were no treatment differences in gait speed change standard deviations [CR-NoCR: -0.002 m/s (95% BCI: -0.013, 0.009)]. Significant mean interactions between CR and exercise assignment [0.037 m/s (95% BCI: 0.004, 0.070)], BMI [0.034 m/s (95% BCI: 0.003, 0.066)], and IL-6 [0.041 m/s (95% BCI: 0.009, 0.073)] were observed, while variance interactions were observed between CR and exercise assignment [-0.458 m/s (95% BCI: -0.783, -0.138)], age [-0.557 m/s (95% BCI: -0.900, -0.221)], and gait speed [-0.530 m/s (95% BCI: -1.018, -0.062)] subgroups. Caloric restriction plus exercise yielded the greatest gait speed benefit among older adults with obesity. High BMI and IL-6 subgroups also improved gait speed in response to CR. Results provide a novel statistical framework for identifying treatment heterogeneity in RCTs.

Predictors of Clinically Meaningful Gait Speed Response to Caloric Restriction Among Older Adults Participating in Weight Loss Interventions.

BACKGROUND: The purpose of this study was to examine whether select baseline characteristics influenced the likelihood of an overweight/obese, older adult experiencing a clinically meaningful gait speed response (±0.05 m/s) to caloric restriction (CR). METHODS: Individual level data from 1 188 older adults participating in 8, 5/6-month, weight loss interventions were pooled, with treatment arms collapsed into CR (n = 667) or no CR (NoCR; n = 521) categories. Exercise assignment was equally distributed across groups (CR: 65.3% vs NoCR: 65.4%) and did not interact with CR (p = .88). Poisson risk ratios (95% confidence interval [CI]) were used to examine whether CR assignment interacted with select baseline characteristic subgroups: age (≥65 years), sex (female/male), race (Black/White), body mass index (BMI; ≥35 kg/m2), comorbidity (diabetes, hypertension, cardiovascular disease) status (yes/no), gait speed (<1.0 m/s), or inflammatory burden (C-reactive protein ≥3 mg/L, interleukin-6 ≥2.5 pg/mL) to influence achievement of ±0.05 m/s fast-paced gait speed change. Main effects were also examined. RESULTS: The study sample (69.5% female, 80.1% White) was 67.6 ± 5.3 years old with a BMI of 33.8 ± 4.4 kg/m2. Average weight loss achieved in the CR versus NoCR group was -8.3 ± 5.9% versus -1.1 ± 3.8%; p < .01. No main effect of CR was observed on the likelihood of achieving a clinically meaningful gait speed improvement (risk ratio [RR]: 1.09 [95% CI: 0.93, 1.27]) or gait speed decrement (RR: 0.77 [95% CI: 0.57, 1.04]). Interaction effects were nonsignificant across all subgroups. CONCLUSION: The proportion of individuals experiencing a clinically meaningful gait speed change was similar for CR and NoCR conditions. This finding is consistent across several baseline subgroupings.

Waist Circumference Change During Intensive Lifestyle Intervention and Cardiovascular Morbidity and Mortality in the Look AHEAD Trial.

OBJECTIVE: The Action for Health in Diabetes (Look AHEAD) trial was a randomized trial comparing effects of intensive lifestyle intervention (ILI) and diabetes support and education (DSE) on cardiovascular disease (CVD) among individuals with overweight/obesity and type 2 diabetes. A secondary analysis was conducted to evaluate the association between change in weight and waist circumference (WC) and CVD outcomes. METHODS: Participants (N = 5,490) were classified into four categories based on change in weight and WC between baseline and year 1 (both increased, both decreased, etc.). Separate Cox proportional hazards regression models were fit for ILI and DSE (using group that reduced weight/WC as reference), and time to first occurrence of primary and secondary CVD outcomes from year 1 through a median of almost 10 years were compared. Second, time to first event among all four ILI groups relative to DSE was evaluated. RESULTS: Within DSE, CVD outcomes did not differ. ILI participants with increased WC had increased risk of primary outcomes, regardless of weight loss (hazard ratio: 1.55 [95% CI: 1.11-2.17]) or weight gain (hazard ratio: 1.76 [95% CI: 1.07-2.89]), and had increased risk of secondary outcomes (overall P < 0.01) relative to ILI participants who reduced both weight and WC and relative to DSE participants. CONCLUSIONS: In this secondary analysis, increased WC during the first year of ILI, independent of weight change, was associated with higher risk for subsequent cardiovascular outcomes.

Bariatric Surgery vs Lifestyle Intervention for Diabetes Treatment: 5-Year Outcomes From a Randomized Trial.

CONTEXT: Questions remain about bariatric surgery for type 2 diabetes mellitus (T2DM) treatment. OBJECTIVE: Compare the remission of T2DM following surgical or nonsurgical treatments. DESIGN, SETTING, AND PARTICIPANTS: Randomized controlled trial at the University of Pittsburgh, in the United States. Five-year follow-up from February 2015 until June 2016. INTERVENTIONS: 61 participants with obesity and T2DM who were initially randomized to either bariatric surgical treatments (Roux-en-Y gastric bypass [RYGB] or laparoscopic adjustable gastric banding [LAGB]) or an intensive lifestyle weight loss intervention (LWLI) program for 1 year. Lower level lifestyle weight loss interventions (LLLIs) were then delivered for 4 years. MAIN OUTCOMES AND MEASURES: Diabetes remission assessed at 5 years. RESULTS: The mean age of the patients was 47 ±â€…6.6 years, 82% were women, and 21% African American. Mean hemoglobin A1c level 7.8% ±â€…1.9%, body mass index (BMI) 35.7 ±â€…3.1 kg/m2, and 26 participants (43%) had BMI < 35 kg/m2. Partial or complete T2DM remission was achieved by 30% (n = 6) of RYGB, 19% (n = 4) of LAGB, and no LWLI participants (P = .0208). At 5 years those in the RYGB group had the largest percentage of individuals (56%) not requiring any medications for T2DM compared with those in the LAGB (45%) and LWLI (0%) groups (P = .0065). Mean reductions in percent body weight at 5 years was the greatest after RYGB 25.2% ±â€…2.1%, followed by LAGB 12.7% ±â€…2.0% and lifestyle treatment 5.1% ±â€…2.5% (all pairwise P < .01). CONCLUSIONS: Surgical treatments are more effective than lifestyle intervention alone for T2DM treatment.

Dietary outcomes within the study of novel approaches to weight gain prevention (SNAP) randomized controlled trial.

BACKGROUND: Young adults (YA) are at high-risk for unhealthy dietary behaviors and weight gain. The Study of Novel Approaches to Weight Gain Prevention (SNAP) Trial demonstrated that two self-regulation approaches were effective in reducing weight gain over 2 years compared with control. The goal of this analysis was to examine effects of intervention on dietary outcomes and the association of diet changes with weight change. METHODS: Participants were 599 YA, age 18-35 years, BMI 21.0-30.0 kg/m2 (27.4 ± 4.4 years; 25.4 ± 2.6 kg/m2; 22% men; 73% non-Hispanic White), who were recruited in Providence, RI and Chapel Hill, NC and randomized to self-regulation with Small Changes (SC), self-regulation with Large Changes (LC) or Control (C). SC and LC emphasized frequent self-weighing to cue behavior changes (small daily changes vs. periodic large changes) and targeted high-risk dietary behaviors. Diet and weight were assessed at baseline, 4 months and 2 years. RESULTS: LC and SC had greater decreases in energy intake than C at 4 months but not 2 years. LC had the greatest changes in percent calories from fat at 4 months, but differences were attenuated at 2 years. No differences in diet quality were observed. Across conditions, increased total energy consumption, fast food, meals away from home, and binge drinking, and decreased dietary quality and breakfast consumption were all associated with weight gain at 2 years. CONCLUSIONS: This study suggests the need to strengthen interventions to produce longer term changes in dietary intake and helps to identify specific behaviors associated with weight gain over time in young adults. TRIAL REGISTRATION: Clinicaltrials.gov # NCT01183689 , registered August 18, 2010.

Self-reported mobility as a preoperative risk assessment tool in older surgical patients compared to the American College of Surgeons National Surgical Quality Improvement Program.

BACKGROUND: The American College of Surgeons National Surgical Quality Improvement Program (NSQIP®) developed a surgical risk calculator using data from 1.4 million patients and including 1557 unique Current Procedural Terminology (CPT) codes. Although this calculator demonstrated excellent performance in predicting postoperative mortality, morbidity, and six surgical complications, it was not developed specifically for use in older surgical patients who have worse surgical outcomes and additional unique risk factors compared to younger adults. We aimed to test the ability of a simple self-reported mobility tool to predict postoperative outcomes in the older surgical population compared to the NSQIP. METHODS: We used data from a prospective cohort study that enrolled 197 older surgical patients (≥ 69 years) undergoing various elective surgeries and assessed 30-day surgical outcomes. Statistical models included data from the Mobility Assessment Tool-short form (MAT-sf) alone, covariates alone, and MAT-sf data and covariates. We used leave-one-out (LOO) cross-validation of the models within our cohort and compared their performance for predicting postoperative outcomes against the NSQIP calculator based on receiver operating characteristic area under the curve (ROC AUC). RESULTS: Patients with poor self-reported mobility experienced higher rates of postoperative complications and nursing home placement. There was no difference in performance between any of our models and the NSQIP calculator (p > 0.1), with AUC between 0.604 and 0.697 for predicting postoperative complications and 0.653 and 0.760 for predicting nursing home placement. All models also predicted a length of stay (LOS) similar to the actual LOS. CONCLUSION: Mobility assessment alone using MAT-sf can predict postoperative complications, nursing home placement, and LOS for older surgical patients, with accuracy comparable to that of the NSQIP calculator. The simplicity of this noninvasive risk assessment tool makes it an attractive alternative to the NSQIP calculator that requires 20 patient predictors and the planned procedure, or CPT code to predict the chance that patients will have 15 different adverse outcomes following surgery.

Impact of a Multidomain Intensive Lifestyle Intervention on Complaints About Memory, Problem-Solving, and Decision-Making Abilities: The Action for Health in Diabetes Randomized Controlled Clinical Trial.

Background: Lifestyle interventions to reduce weight and increase activity may preserve higher-order cognitive abilities in overweight/obese adults with type 2 diabetes (T2D). Methods: Adults (N = 5,084) with T2D who enrolled in a randomized clinical trial of a 10-year intensive lifestyle intervention (ILI) compared with diabetes support and education were queried at baseline and repeatedly during follow-up for complaints about difficulties in memory, problem-solving, and decision-making abilities. Results: For those without baseline complaints, assignment to ILI was associated with lower odds that complaints would emerge during follow-up for decision-making ability (odds ratio [OR]=0.851, [95% CI, 0.748,0.967], p=0.014), and, among individuals who were not obese, lower odds that complaints would emerge about problem-solving ability (OR=0.694 [0.510,0.946]). No cognitive benefits from ILI were seen for individuals with baseline complaints about cognitive abilities. ILI may have exacerbated the severity of complaints about problem-solving ability during follow-up among individuals with baseline complaints and cardiovascular disease (OR=2.949 [1.378,6.311]). Conclusions: A long-term multidomain ILI may reduce the likelihood that complaints about difficulties in higher-order cognitive abilities will emerge in T2D adults without pre-existing complaints. Among those with pre-existing complaints, the ILI did not prevent increases in complaint severity.

Physical Function Following a Long-Term Lifestyle Intervention Among Middle Aged and Older Adults With Type 2 Diabetes: The Look AHEAD Study.

Background: Lifestyle interventions have been shown to improve physical function over the short term; however, whether these benefits are sustainable is unknown. The long-term effects of an intensive lifestyle intervention (ILI) on physical function were assessed using a randomized post-test design in the Look AHEAD trial. Methods: Overweight and obese (body mass index ≥ 25 kg/m2) middle-aged and older adults (aged 45-76 years at enrollment) with type 2 diabetes enrolled in Look AHEAD, a trial evaluating an ILI designed to achieve weight loss through caloric restriction and increased physical activity compared to diabetes support and education (DSE), underwent standardized assessments of performance-based physical function including a 4- and 400-m walk, lower extremity physical performance (expanded Short Physical Performance Battery, SPPBexp), and grip strength approximately 11 years postrandomization and 1.5 years after the intervention was stopped (n = 3,783). Results: Individuals randomized to ILI had lower odds of slow gait speed (<0.8 m/s) compared to those randomized to DSE (adjusted OR [95% CI]: 0.84 [0.71 to 0.99]). Individuals randomized to ILI also had faster gait speed over 4- and 400-m (adjusted mean difference [95% CI]: 0.019 [0.007 to 0.031] m/s, p = .002, and 0.023 [0.012 to 0.034] m/sec, p < .0001, respectively) and higher SPPBexp scores (0.037 [0.011 to 0.063], p = .005) compared to those randomized to DSE. The intervention effect was slightly larger for SPPBexp scores among older versus younger participants (0.081 [0.038 to 0.124] vs 0.013 [-0.021 to 0.047], p = .01). Conclusions: An intensive lifestyle intervention has modest but significant long-term benefits on physical function in overweight and obese middle-aged and older adults with type 2 diabetes. ClinicalTrials.gov Identifier: NCT00017953.

Three-Year Outcomes of Bariatric Surgery vs Lifestyle Intervention for Type 2 Diabetes Mellitus Treatment: A Randomized Clinical Trial.

IMPORTANCE: Questions remain about the role and durability of bariatric surgery for type 2 diabetes mellitus (T2DM). OBJECTIVE: To compare the remission of T2DM following surgical and nonsurgical treatments. DESIGN, SETTING, AND PARTICIPANTS: In this 3-arm randomized clinical trial conducted at the University of Pittsburgh Medical Center from October 1, 2009, to June 26, 2014, in Pittsburgh, Pennsylvania, outcomes were assessed 3 years after treating 61 obese participants aged 25 to 55 years with T2DM. Analysis was conducted with an intent-to-treat population. INTERVENTIONS: Participants were randomized to either an intensive lifestyle weight loss intervention for 1 year followed by a low-level lifestyle intervention for 2 years or surgical treatments (Roux-en-Y gastric bypass [RYGB] or laparoscopic adjustable gastric banding [LAGB]) followed by low-level lifestyle intervention in years 2 and 3. MAIN OUTCOMES AND MEASURES: Primary end points were partial and complete T2DM remission and secondary end points included diabetes medications and weight change. RESULTS: Body mass index (calculated as weight in kilograms divided by height in meters squared) was less than 35 for 26 participants (43%), 50 (82%) were women, and 13 (21%) were African American. Mean (SD) values were 100.5 (13.7) kg for weight, 47.3 (6.6) years for age, 7.8% (1.9%) for hemoglobin A1c level, and 171.3 (72.5) mg/dL for fasting plasma glucose level. Partial or complete T2DM remission was achieved by 40% (n = 8) of RYGB, 29% (n = 6) of LAGB, and no intensive lifestyle weight loss intervention participants (P = .004). The use of diabetes medications was reduced more in the surgical groups than the lifestyle intervention-alone group, with 65% of RYGB, 33% of LAGB, and none of the intensive lifestyle weight loss intervention participants going from using insulin or oral medication at baseline to no medication at year 3 (P < .001). Mean (SE) reductions in percentage of body weight at 3 years were the greatest after RYGB at 25.0% (2.0%), followed by LAGB at 15.0% (2.0%) and lifestyle treatment at 5.7% (2.4%) (P < .01). CONCLUSIONS AND RELEVANCE: Among obese participants with T2DM, bariatric surgery with 2 years of an adjunctive low-level lifestyle intervention resulted in more disease remission than did lifestyle intervention alone. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01047735.

Racial Differences in Weight Loss Among Adults in a Behavioral Weight Loss Intervention: Role of Diet and Physical Activity.

BACKGROUND: African-Americans lose less weight during a behavioral intervention compared with Whites, which may be from differences in dietary intake or physical activity. METHODS: Subjects (30% African American, 70% White; n = 346; 42.4 ± 9.0 yrs.; BMI = 33.0 ± 3.7 kg/m2) in an 18-month weight loss intervention were randomized to a standard behavioral (SBWI) or a stepped-care (STEP) intervention. Weight, dietary intake, self-report and objective physical activity, and fitness were assessed at 0, 6, 12, and 18 months. RESULTS: Weight loss at 18 months was greater in Whites (-8.74 kg with 95% CI [-10.10, -7.35]) compared with African Americans (-5.62 kg with 95% CI [-7.86, -3.37]) (P = .03) in the SBWI group and the STEP group (White: -7.48 kg with 95% CI [-8.80, -6.17] vs. African American: -4.41kg with 95% CI [-6.41, -2.42]) (P = .01). Patterns of change in dietary intake were not different between groups. Objective physical activity (PA) changed over time (P < .0001) and was higher in Whites when compared with African Americans (P = .01). CONCLUSIONS: Whites lost more weight (3.10 kg) than African American adults. Although there were no differences in dietary intake, Whites had higher levels of objective PA and fitness. Thus, the discrepancy in weight loss may be due to differences in PA rather than dietary intake. However, the precise role of these factors warrants further investigation.

Time-based physical activity interventions for weight loss: a randomized trial.

PURPOSE: This study aims to examine whether enhancing standard behavioral weight loss interventions (standard behavioral weight loss program (SBWP)) with additional strategies at the initiation of intervention (ADOPT) or providing the additional strategies at predetermined times over the intervention period (MAINTAIN) enhances 18-month weight loss. METHODS: This was a clinical trial of participants (N = 195; mean ± SEM: age, 43.2 ± 8.6 yr; body mass index, 33.0 ± 3.4 kg·m) randomized to SBWP, ADOPT, or MAINTAIN. All participants were prescribed an energy-restricted diet and physical activity, with group intervention sessions delivered over 18 months. ADOPT participants received additional phone contact (months 1-3), supervised exercise (months 1-6), and behavior campaigns (months 4-9). MAINTAIN participants received additional phone contact (months 4-6), supervised exercise (months 7-12), and behavior campaigns (months 13-18). RESULTS: There was a significant group-time interaction for weight loss (P = 0.0032). SBWP participants lost 9.3 ± 0.9, 7.8 ± 1.1, and 5.9 ± 1.2 kg at 6, 12, and 18 months, respectively. ADOPT participants lost 8.9 ± 0.9, 7.6 ± 1.2, and 5.8 ± 1.2 kg, whereas MAINTAIN participants lost 9.7 ± 0.9, 11.0 ± 1.2, and 9.0 ± 1.2 kg at 6, 12, and 18 months, respectively. The group-time interactions for SBWP versus MAINTAIN (P = 0.0033) and for ADOPT versus MAINTAIN (P = 0.0075) were significant. There was a significant group-time interaction for change in fitness (P = 0.0060). The group-time interaction for MAINTAIN versus ADOPT (P = 0.0018) was significant, with a trend for MAINTAIN versus SBWP (P = 0.0525). CONCLUSIONS: MAINTAIN improves 18-month weight loss compared with SBWP and ADOPT, with statistical trends indicating that MAINTAIN results in greater improvements in fitness. These results suggest that time-based strategies emphasizing physical activity confer greater benefits when delivered later and over the full course of intervention. This provides valuable information for the implementation of time-based strategies for improving long-term weight loss and fitness in overweight and obese adults.

Glove and gown effects on intraoperative bacterial contamination.

OBJECTIVE: Experiments were performed to determine the risk of bacterial contamination associated with changing outer gloves and using disposable spunlace paper versus reusable cloth gowns. BACKGROUND: Despite decades of research, there remains a lack of consensus regarding certain aspects of optimal aseptic technique including outer glove exchange while double-gloving and surgical gown type selection. METHODS: In an initial glove study, 102 surgical team members were randomized to exchange or retain outer gloves 1 hour into clean orthopedic procedures; cultures were obtained 15 minutes later from the palm of the surgeon's dominant gloved hand and from the surgical gown sleeve. Surgical gown type selection was recorded. A laboratory strike-through study investigating bacterial transmission through cloth and paper gowns was performed with coagulase-negative staphylococci. In a follow-up glove study, 251 surgical team members, all wearing paper gowns, were randomized as in the first glove study. RESULTS: Glove study 1 revealed 4-fold higher levels of baseline bacterial contamination (31% vs 7%) on the sleeve of surgical team members wearing cloth gowns than those using paper gowns [odds ratio (95% confidence interval): 4.64 (1.72-12.53); P = 0.0016]. The bacterial strike-through study revealed that 26 of 27 cloth gowns allowed bacterial transmission through the material compared with 0 of 27 paper gowns (P < 0.001). In glove study 2, surgeons retaining outer gloves 1 hour into the case had a subsequent positive glove contamination rate of 23% compared with 13% among surgeons exchanging their original outer glove [odds ratio (95% confidence interval): 1.97 (1.02-3.80); P = 0.0419]. CONCLUSIONS: Paper gowns demonstrated less bacterial transmission in the laboratory and lower rates of contamination in the operating room. Disposable paper gowns are recommended for all surgical cases, especially those involving implants, because of the heightened risk of infection. Outer glove exchange just before handling implant materials is also recommended to minimize intraoperative contamination.

25-Hydroxyvitamin D, parathyroid hormone, and mortality in black and white older adults: the health ABC study.

CONTEXT: Previous 25-hydroxyvitamin D [25(OH)D] and mortality studies have included mostly individuals of European descent. Whether the relationship is similar in Blacks and to what extent differences in 25(OH)D explain racial disparities in mortality is unclear. OBJECTIVE: The objective of the study was to examine the relationship between 25(OH)D, PTH, and mortality in Black and white community-dwelling older adults over 8.5 yr of follow-up. DESIGN AND SETTING: Health ABC is a prospective cohort study conducted in Memphis, TN, and Pittsburgh, PA. PARTICIPANTS: Well-functioning Blacks and whites aged 71-80 yr with measured 25(OH)D and PTH (n = 2638; 49% male, 39% Black) were included in the study. MAIN OUTCOME MEASURE: Multivariate-adjusted proportional hazards models estimated the hazard ratios (HR) for all-cause, cardiovascular, cancer, and noncancer, noncardiovascular mortality (n = 691 deaths). RESULTS: Mean 25(OH)D concentrations were higher in whites than in Blacks [mean (sd): 29.0 (9.9) and 20.8 (8.7) ng/ml, respectively; P < 0.001]. Serum 25(OH)D by race interactions were not significant, however. Lower 25(OH)D concentrations were associated with higher mortality in Blacks and whites combined [HR (95% confidence interval [CI] 2.27 (1.59-3.24), 1.48 (1.20-1.84), and 1.25 (1.02-1.52) for < 10, 10 to < 20, and 20 to < 30 vs. ≥30 ng/ml]. In the multivariate model without 25(OH)D, Blacks had 22% higher mortality than whites [HR (95% CI) 1.22 (1.01, 1.48)]; after including 25(OH)D in the model, the association was attenuated [1.09 (0.90-1.33)]. The mortality population attributable risks (95% CI) for 25(OH)D concentrations less than 20 ng/ml and less than 30 ng/ml in Blacks were 16.4% (3.1-26.6%) and 37.7% (11.6-55.1%) and in whites were 8.9% (3.9-12.7%) and 11.1% (-2.7 to 22.0%), respectively. PTH was also associated with mortality [HR (95% CI) 1.80 (1.33-2.43) for ≥70 vs. <23 pg/ml]. CONCLUSIONS: Low 25(OH)D and high PTH concentrations were associated with increased mortality in Black and white community-dwelling older adults. Because 25(OH)D concentrations were much lower in Blacks, the potential impact of remediating low 25(OH)D concentrations was greater in Blacks than whites.

Patterns of weight change associated with long-term weight change and cardiovascular disease risk factors in the Look AHEAD Study.

This article provides an assessment of the associations that weight-loss patterns during the first year of an intensive lifestyle intervention have with 4-year maintenance and health outcomes. Two components described patterns of weight change during the first year of intervention: one reflected the typical pattern of weight loss over the 12 months, but distinguished those who lost larger amounts across the monthly intervals from those who lost less. The second component reflected the weight change trajectory, and distinguished a pattern of initial weight loss followed by regain vs. a more sustained pattern of weight loss. Two thousand four hundred and thirty eight individuals aged 45-76 years with type 2 diabetes mellitus, who enrolled in the weight-loss intervention of a randomized clinical trial, were assigned scores according to how their weight losses reflected these patterns. Relationships these scores had with weight losses and health outcomes (glycosolated hemoglobin--hemoglobin A1c (HbA1c); systolic blood pressure, high-density lipoprotein (HDL)-cholesterol, and triglycerides) over 4 years were described. When compared to those with lower scores on the two components, both individuals who had larger month-to-month weight losses in year 1 and whose weight loss was more sustained during the first year had better maintenance of weight loss over 4 years, independent of characteristics traditionally linked to weight loss success (P < 0.001). While relationships with year 4 weight loss were stronger, the pattern of larger monthly weight loss during year 1 was also independently predictive of year 4 levels of HbA1c, HDL-cholesterol, and systolic blood pressure.

One-year weight losses in the Look AHEAD study: factors associated with success.

This report provides a further analysis of the first year weight losses in the Look AHEAD (Action for Health in Diabetes) study and identifies factors associated with success. Participants were a total of 5,145 men and women with type 2 diabetes who were recruited at 16 sites and randomly assigned to an intensive lifestyle intervention (ILI) or a control condition, Diabetes Support and Education (DSE). During year 1, participants in ILI received comprehensive diet and physical activity counseling in a total of 42 group and individual sessions, compared with three educational sessions for DSE participants. As reported previously, at the end of the year, ILI participants lost 8.6% of initial weight, compared to 0.7% for DSE (P < 0.001). Within the ILI group, all racial/ethnic groups achieved clinically significant weight losses (>5.5%), although there were significant differences among groups. For the year, ILI participants attended an average of 35.4 treatment sessions and reported exercising a mean of 136.6 min/week and consuming a total of 360.9 meal replacement products. Greater self-reported physical activity was the strongest correlate of weight loss, followed by treatment attendance and consumption of meal replacements. The use of orlistat, during the second half of the year, increased weight loss only marginally in those ILI participants who had lost <5% of initial weight during the first 6 months and chose to take the medication thereafter as a toolbox option. The lifestyle intervention was clinically effective in all subsets of an ethnically and demographically diverse population.

Viewing professional wrestling on television and engaging in violent and other health risk behaviors.

BACKGROUND: This study examined the relationships between watching wrestling on television (TV) and engaging in health risk behaviors among an older multi-state sample of adolescents. METHODS: In 2001, a random sample of 2,307 youth ages 16 to 20 years from 138 communities in 17 US states completed telephone surveys as part of the national evaluation of the Enforcing Underage Drinking Laws Program. The survey measured multiple health risk behaviors, including substance use, involvement in date fighting, other violent behaviors, and sexual risk behaviors. The frequency of watching wrestling on TV during the two week period before the survey was measured with a scale of 0 to 14 or more times. Multivariate analyses were conducted with logistic regression using a generalized estimating equation (GEE) model with an exchangeable correlation structure that controlled for within-group clustering. Data are presented as adjusted odds ratios (OR) and 95% confidence intervals. RESULTS: Males (22.4%) reported watching wrestling more than females (13.6%). After adjusting for ethnicity, sex, median family income, age, region of the country, other fighting behaviors, and family composition, the frequency of watching wrestling was associated with having tried to hurt someone with a weapon (OR = 1.67, CI = 1.05-2.66), engaging in sexual intercourse without using birth control (1.42, 1.01-1.98), being a current cigarette smoker (1.31, 1.02-1.69), and not drinking (0.64, 0.48-0.85). When the frequency of watching wrestling was treated as an independent variable, after adjusting for covariates, each additional time wrestling was watched on TV was associated with an increased risk of being in a date fight (1.16, 1.02-1.30), threatening to hurt someone with a weapon (1.14, 1.02-1.28), hurting someone with a weapon (1.19, 105-1.34), and engaging in sexual intercourse without using birth control (1.13, 1.03-1.23). For example, youth who had watched wrestling six times during the past two weeks were 144% more likely to have engaged in a date fight than adolescents who had not watched wrestling. CONCLUSIONS: The more frequently these adolescents reported watching wrestling on TV, the more likely they were to engage in violent and other health risk behaviors.

Fitness, fatness, and cardiovascular risk factors in type 2 diabetes: look ahead study.

PURPOSE: Most studies comparing the effects of fitness and fatness on cardiovascular (CVD) risk have been done with young, healthy participants with low rates of obesity and high levels of fitness. The present study examined the association of cardiorespiratory fitness and obesity with CVD risk factors in an ethnically diverse sample of overweight/obese individuals with type 2 diabetes. METHOD: Baseline data from Look AHEAD, a study of 5145 overweight or obese individuals with type 2 diabetes, were used to examine the association of BMI categories (overweight, class I, II, or III obesity) and cardiorespiratory fitness (assessed with a maximal graded exercise test and categorized by age- and gender-specific quintiles) on cardiovascular risk factors and on the odds of having hypertension, hyperlipidemia, or HbA1c > or = 7%. RESULTS: BMI categories and fitness quintiles were highly associated with each other (P < 0.0001), with the heaviest participants being the least fit. Only 2-3% of participants had class III obesity and were in the two fittest quintiles or, conversely, were overweight and in the two least-fit quintiles. When fitness and BMI were included in the same model (adjusting for age, smoking, diabetes duration, and race), HbA1c, ankle/brachial index (ABI), and Framingham risk score were most strongly associated with fitness. Systolic blood pressure was most strongly associated with BMI category. Similar results occurred when waist circumference and fitness were considered together. CONCLUSION: In this large, ethnically diverse sample of overweight/obese individuals with type 2 diabetes, fitness and fatness were highly related to each other but seemed to have different impact on specific CVD risk factors.